Method and apparatus for sealing access

ABSTRACT

An apparatus and a method for sealing a puncture in a tubular tissue structure or the wall of a body cavity are provided. The apparatus and method include a bioabsorbable member that is partially external to and partially internal to an introducer sheath before and during placement thereof.

CLAIM FOR PRIORITY

The present application claims priority to U.S. Provisional Application61/061,823 filed Jun. 16, 2008, the disclosure of which is incorporatedherein by reference.

FIELD OF THE DISCLOSURE

The present disclosure relates to an apparatus and a method for sealinga puncture in a tubular tissue structure or the wall of a body cavity.More particularly, the present disclosure is directed to sealing apuncture site with submucosal tissue or another extracellularmatrix-derived tissue capable of remodeling endogenous connective tissueor with a synthetic bioabsorbable material.

BACKGROUND AND SUMMARY

The control of bleeding during and after surgery is important to thesuccess of the procedure. The control of blood loss is of particularconcern if the surgical procedure is performed directly upon or involvesthe patient's arteries and veins. Well over one million surgicalprocedures are performed annually which involve the insertion andremoval of catheters into and from arteries and veins. Accordingly,these types of vasculature procedures represent a significant amount ofsurgery in which the control of bleeding is of particular concern.

Typically, the insertion of a catheter creates a puncture through thevessel wall and upon removal the catheter leaves a puncture openingthrough which blood may escape and leak into the surrounding tissues.Therefore, unless the puncture site is closed clinical complications mayresult leading to increased hospital stays with the associated costs. Toaddress this concern, medical personnel are required to provide constantand continuing care to a patient who has undergone a procedure involvingan arterial or venous puncture to insure that post-operative bleeding iscontrolled.

Surgical bleeding concerns can be exacerbated by the administration of ablood thinning agent, such as heparin, to the patient prior to acatheterization procedure. Since the control of bleeding inanti-coagulated patients is much more difficult to control, stemmingblood flow in these patients can be troublesome. A common method ofhealing the puncture to the vessel is to maintain external pressure overthe vessel until the puncture seals by natural clot formation processes.This method of puncture closure typically takes about thirty to ninetyminutes, with the length of time usually being greater if the patient ishypertensive or anti-coagulated.

Furthermore, it should be appreciated that utilizing pressure, such ashuman hand pressure, to control bleeding suffers from several drawbacksregardless of whether the patient is hypertensive or anti-coagulated. Inparticular, when human hand pressure is utilized, it can beuncomfortable for the patient, can result in excessive restriction orinterruption of blood flow, and can use costly professional time on thepart of the hospital staff. Other pressure techniques, such as pressurebandages, sandbags, or clamps require the patient to remain motionlessfor an extended period of time and the patient must be closely monitoredto ensure the effectiveness of these techniques.

Other devices have been disclosed which plug or otherwise provide anobstruction in the area of the puncture (see, for example, U.S. Pat.Nos. 4,852,568 and 4,890,612) wherein a collagen plug is disposed in theblood vessel opening. When the plug is exposed to body fluids, it swellsto block the wound in the vessel wall. A potential problem with plugsintroduced into the vessel is that particles may break off and floatdownstream to a point where they may lodge in a smaller vessel, causingan infarct to occur. Another potential problem with collagen plugs isthat there is the potential for the inadvertent insertion of thecollagen plug into the lumen of the blood vessel which is hazardous tothe patient. Collagen plugs also can act as a site for plateletaggregation, and, therefore, can cause intraluminal deposition ofocclusive material creating the possibility of a thrombosis at thepuncture sight. Other plug-like devices are disclosed, for example, inU.S. Pat. Nos. 5,342,393, 5,370,660 and 5,411,520.

Accordingly, there is a need for surgical techniques suitable forsealing punctures in a tubular tissue structure or in the punctured wallof a body cavity, such as a heart chamber, or a body cavity of anotherorgan. Such techniques require rapid, safe, and effective sealing of thepuncture. It would also be useful to close the puncture withoutdisposing any occlusive material into the vessel or body cavity, andwithout introducing infectious organisms into the patient's circulatorysystem.

The present disclosure is directed to an apparatus and method forsealing punctured tubular tissue structures, including arteries andveins, such as punctures which occur during diagnostic andinterventional vascular and peripheral catheterizations, or for sealinga puncture in the wall of a body cavity. More specifically, theapparatus and method of the present disclosure employ submucosal tissueor another extracellular matrix-derived tissue or a syntheticbioabsorbable material to seal punctures in tubular tissue structures,such as blood vessels, or in the wall of a body cavity. The submucosaltissue or other extracellular matrix-derived tissue is capable ofinducing tissue remodeling at the site of implantation by supporting thegrowth of connective tissue in vivo, and has the added feature of beingtear-resistant so that occlusive material is not introduced into thepatient's circulatory system. Also, submucosal tissue or anotherextracellular matrix-derived tissue has the feature of being resistantto infection, thereby reducing the chances that the procedure willresult in systemic infection of the patient.

In one embodiment, a device for sealing a puncture site in the wall of abody is provided. The device comprising an elongated element having atissue wall contact exterior portion and having a length adapted to beinserted into the puncture site so that the length forms intravascular,intermediate and extracorporeal portions, and a bioabsorbable memberreleasably attached to the tissue wall contact exterior portion of theelongated element.

In another embodiment a device for sealing a puncture site in the wallof a blood vessel is provided. The device comprising an elongatedelement having a tissue wall contact exterior portion and abioabsorbable member releasably attached to the tissue wall contactexterior portion of the elongated element.

In an alternate embodiment a method of sealing a puncture site in tissueis disclosed. The method comprises the steps of providing an elongatedelement having a bioabsorbable member disposed on the exterior thereof,the elongated element being configured to be introduced into a body withthe bioabsorbable member disposed thereon; and providing a depositmember that allows the bioabsorbable member to be left within a bodywhen the elongated element is removed from the body.

In another embodiment a method of sealing a puncture site in the wall ofa body cavity is provided. The method comprises the step of providing anaccess device having an elongated element having a lumen therein and atissue wall contact exterior portion and having a bioabsorbable memberreleasably disposed on the tissue wall contact exterior portion of theelongated element; placing the access device in contact with tissue;locating an instrument within the lumen of the elongated element;releasing the bioabsorbable member from the elongated element; andremoving the elongated element from contact with tissue while allowingthe bioabsorbable member to remain in contact with the tissue.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates an introducer element for use in sealing access to atubular tissue structure or a body cavity partially disposed in atubular tissue structure;

FIGS. 2 & 2A illustrates the introducer element of FIG. 1 with a graftsheet deployed therefrom;

FIG. 3 illustrates the graft sheet secured in the tubular tissuestructure;

FIGS. 4A & 4B show the graft sheet and tether attached thereto; and

FIGS. 5A & 5B show the introducer element and graft sheet outside of theanatomy and pre-deployment.

DETAILED DESCRIPTION

The disclosures of U.S. application Ser. Nos. 11/180,379, 10/863,703,10/166,399, 11/879,426, 11/546,079, and 60/297,060 are incorporatedherein by reference. The present disclosure is related to an apparatusand a method for sealing a puncture in a tubular tissue structure, suchas a blood vessel, or in the wall of a body cavity, with submucosaltissue, another extracellular matrix-derived tissue, or a syntheticbioabsorbable material capable of supporting the growth of endogenousconnective tissue in vivo resulting in remodeling of endogenousconnective tissue at the puncture site and in formation of a staticseal. The apparatus and method of the present disclosure can be used toseal a puncture in a tubular tissue structure, such as a blood vessel,or in the wall of a body cavity, that has been created intentionally orunintentionally during a surgical procedure or nonsurgically (e.g.,during an accident). Punctures made intentionally include vascularpunctures made in various types of vascular, endoscopic, or orthopaedicsurgical procedures, or punctures made in any other type of surgicalprocedure, in coronary and in peripheral arteries and veins or in thewall of a body cavity. Such procedures include angiographic examination,angioplasty, laser angioplasty, valvuloplasty, atherectomy, stentdeployment, rotablator treatment, aortic prosthesis implantation,intraortic balloon pump treatment, pacemaker implantation, anyintracardiac procedure, electrophysiological procedures, interventionalradiology, and various other diagnostic, prophylactic, and therapeuticprocedures such as dialysis and procedures relating to percutaneousextracorporeal circulation.

Referring now to the drawings, FIG. 1 illustrates an introducer 10adapted for catheterization, exemplary of the type of introducer elementthat may be used in accordance with the present disclosure. Although anintroducer 10 adapted for use in catheterization procedures isillustrated in FIG. 1, it is understood that the present disclosure isapplicable to any type of introducer element used to provide access tothe lumen of a tubular tissue structure, such as a blood vessel, or to abody cavity. For example, the present disclosure is applicable to anintroducer element such as a needle, a cannula, a guide wire, anintroducer element adapted for dialysis, a trocar, or any otherintroducer element used to access the lumen of a tubular tissuestructure or a body cavity.

An introducer 10 as depicted in FIG. 1 can be used when performingcatheterization procedures in coronary and peripheral arteries and veins1000. Typically, a catheter is introduced into the vascular system byfirst penetrating the skin 1010, underlying muscle tissue 1020, and theblood vessel 1000 with a needle, and guide wire 1030 is inserted throughthe lumen of the needle and enters the blood vessel. Subsequently, theneedle is stripped off the guide wire and introducer 10 is fed overguide wire 1030 and pushed through skin 1010 and through the vessel wallto enter vessel 1000. Guide wire 1030 can then be removed and a catheteris fed through the lumen of the introducer 10 and advanced through thevascular system until the working end of the catheter is positioned at apredetermined location. Alternatively, guide wire 1030 may be left inplace throughout the procedure and the introducer 10 removed beforeguide wire 1030 is removed. At the end of the catheterization procedure,the catheter is withdrawn. Introducer 10 is also removed and the openingthrough which, for example, introducer 10 is inserted must be sealed asquickly as possible once the procedure is completed. Although a typicalcatheterization procedure utilizing introducer 10 is described, thedescribed procedure is non-limiting. Furthermore any embodiment ofintroducer 10 described below is applicable to any other introducerelement for use in accessing the lumen of a tubular tissue structure ora body cavity.

The present disclosure may be employed, for example, to rapidly seal apuncture site in a blood vessel upon completion of a catheterizationprocedure. Introducer 10 illustrated in FIG. 1 is an exemplaryembodiment and has a user distal end 12 for insertion into blood vessel1000 and a user proximal end 14. A standard introducer comprises dilator17 and sheath 16 which extends axially over dilator 17, sheath cap 20disposed axially over a portion of sheath 16 and valve cap 22 connectedto sheath cap 20 and to side port tube 24. Dilator 17 includes a sectionof decreased diameter (not shown) that provides clearance within sheath16 for flexible portion 19 of sheet 18 when flexible portion 19 isdisposed within sheath 16 as discussed below. A standard introducer mayalso comprise three-way valve 26 connected to an end of the side porttube 24, and syringe connector 28, adapted for the attachment of asyringe to introducer 10 and connected to valve cap 22. Although notpart of a standard introducer, introducer 10 depicted in FIG. 1 furthercomprises sheet 18 of submucosal tissue or another extracellularmatrix-derived tissue or a synthetic bioabsorbable material extendingaxially over a portion of sheath 16.

In the embodiment of the disclosure depicted in FIG. 1, sheet 18 ofsubmucosal tissue or another extracellular matrix-derived tissue or asynthetic bioabsorbable material includes cuff section 122 that extendsaxially over a portion of sheath 16. Sheet 18 further includes flexiblesection 19 at a user distal end 30 that is disposed within sheath 16prior to deployment. To this end, sheath 16 includes an access hole 21that receives flexible section 19 therein while allowing cuff section122 to remain outside and around sheath 16. Distal end 30 of sheath 16is inserted into tubular tissue structure 1000, such as a blood vessel,and user proximal end 32 remains outside of the punctured vessel wall.Proximal end 32, cuff 122, of the sheet 18 extends axially over aportion of the introducer 10 as depicted in FIG. 1.

Cuff section 122 of sheet 18 may be held in place on sheath 16, forexample, by a retaining tether (not shown) or other line attachedthereto and to sheath cap 20 or valve cap 22. Cuff section 122 includesa loop 124 at a distal end thereof that passes through retaining hole123 (see FIG. 5B) and is selectively engaged by the retaining tether.Retaining hole 123 is located at the substantially equal axial positionas access hole 21 and offset therefrom by 90-degrees. As a result of theengagement between the loop and the retaining tether, cuff section 122is prevented from being pushed along introducer 10 when the user insertsintroducer 10 through, for example, a vessel wall with his hand incontact with sheet 18 or from friction provided by skin 1010, muscle1020, or other encountered anatomy. Introducer 10 is inserted into theanatomy until cuff section 122 abuts the wall of vessel 1000, or otherdesired structure, as shown in FIG. 1. Such abutment provides increasedresistance and tactile feedback indicating that cuff 122 is positionedat vessel 1000. Once positioned, the retaining tether may be removed topermit relative movement between sheet 18 (including cuff 122) andsheath 16.

Once sheet 18 is permitted to move relative to sheath 16, sheath 16 isfurther advanced into vessel 1000. During the moving of sheath 16, sheet18 is held in place via the abutment of cuff section 122 against thewall of vessel 1000. Such relative movement results in flexible portion19 being extracted from within sheath 16 through access hole 21 untilflexible portion 19 is fully outside of sheath 16 and within vessel1000.

As shown in FIGS. 1 and 2, in one illustrative embodiment the sheet 18has a second tether 37 attached at or near to the proximal end 32 of thesheet 18.

Tether 37 is attached to sheet 18, see FIGS. 4 a, 4 b, at or nearproximal end 32 of sheet 18 and extends axially downwards throughflexible portion 19 towards distal end 30 of sheet 18 and then back upthrough flexible portion 19 towards proximal end 32. Tether 37 isthreaded through sheet 18 at many places. Thus, portions of tether 37are inserted into blood vessel 1000 when the introducer 10 is pushedthrough the vessel wall and the proximal end 43 of tether 37 remainsexternally exposed.

Upon completion of the procedure, such as catheterization, or beforecompletion if desired, proximal end 43 of tether 37 is pulled to gatherdistal end 30 of sheet 18 in the puncture site or on the inside of thevessel wall (see FIG. 3). Subsequent retracting of sheath 16 leavesgathered sheet 18 to form a plug at the puncture site of the vesselwall.

Sheet 18 may have any combination of tethers 37 and retaining tethers,or may lack one or more types of tethers. For example, the sheet 18 maylack a retaining tether. In this embodiment where only tether 37 isattached to the sheet 18, tether 37 is used to gather the sheet 18 inthe puncture site and against the inside of the vessel wall.

Tethers with different functions (i.e., the retaining tether and tether37) may have different indicia disposed thereon, such as differentcolors, so that the user can easily identify the tether with the desiredfunction. Alternatively, tethers with different functions may havedifferent caps attached to the externally exposed ends so that thetether with the desired function can be easily identified. In oneillustrative embodiment, the tethers are made of resorbable thread andthe tethers can be attached to the sheet 18 by any suitable means. Forexample, the tethers can be tied to the sheet 18, hooked to the sheet 18by using hooks, barbs, etc. (e.g., for tethers with attachment pointsthat remain externally exposed when the introducer 10 is inserted intothe vessel wall), or woven/sewn into sheet 18 as shown in FIGS. 4 a & 4b.

While certain embodiments of the present disclosure have been describedin detail, those familiar with the art to which this disclosure relateswill recognize various alternative designs and embodiments forpracticing the disclosure as defined by the following claims.

What is claimed is:
 1. A device for sealing a puncture site in a wall of a blood vessel comprising: an elongated element having a length adapted to be inserted into the puncture site and having a distal end, a proximal end, and an access port disposed in a wall of the elongated element spaced apart from and between the distal end and the proximal end, and a bioabsorbable member including an external portion disposed on the exterior of the elongated element, a portion extending through the access port of the elongated element, and an internal portion within the elongated element, the bioabsorbable member being releasably fixed to the elongated element.
 2. The device of claim 1, wherein the elongated element has a tissue wall contact exterior portion.
 3. The device of claim 1, wherein the length of the elongated element forms intravascular, intermediate and extracorporeal portions.
 4. The device of claim 1, wherein the bioabsorbable member includes a cuff portion disposed on the exterior of the elongated element.
 5. The device of claim 4, wherein the cuff portion forms a lumen that receives the elongated element therein.
 6. The device of claim 4, wherein the cuff portion is slideable relative to the elongated element.
 7. The device of claim 6, wherein sliding of the cuff relative to the elongated element causes at least some of the bioabsorbable member disposed within the elongated element to be withdrawn from the elongated element via the access port.
 8. The device of claim 1, further including a removable tether that fixes the position of the external portion of the bioabsorbable member.
 9. The device of claim 1, wherein the access port has a fixed location in the wall of the elongated element.
 10. The device of claim 1, wherein the wall of the elongated element is made of a first material, the access port being defined in the wall such that all sides of the access port are defined by the first material.
 11. The device of claim 1, wherein the elongated element further includes a lumen extending between distal end and the proximal end, at the internal portion having a first position in which the internal portion is disposed within the lumen.
 12. The device of claim 1, wherein the access port is sized such that it extends less than all the way around the perimeter of the elongated element.
 13. The device of claim 12, wherein the access port is sized such that it extends less than half way around the elongated element.
 14. The device of claim 1, wherein the elongated element includes a portion of constant diameter, the access port being defined in the portion of constant diameter.
 15. The device of claim 1, wherein the elongated element is of a homogenous construction.
 16. The device of claim 1, wherein the access port defines a central port axis, the central port is not collinear with a central axis of the elongated element.
 17. The device of claim 16, wherein the central port axis is not parallel with the central axis of the elongated element.
 18. The device of claim 1, wherein the bioabsorbable member has a first position wherein the portion within the elongated element is longer than the portion disposed on the exterior of the elongated element.
 19. The device of claim 1, wherein the elongated element is of fixed construction, having no moving parts.
 20. The device of claim 1, wherein the elongated element has a fixed length.
 21. The device of claim 1, wherein the elongated element is an introducer sheath.
 22. The device of claim 1, further including a dilator partially disposed within the elongated element.
 23. The device of claim 1, wherein the elongated element defines a central axis of the elongated element, the external portion of the bioabsorbable member being a first distance away from the central axis, the internal portion of the bioabsorbable member being a second distance away from the central axis, the first distance being different than the second distance.
 24. The device of claim 1, wherein the internal portion of the bioabsorbable member is planar.
 25. The device of claim 1, wherein the access port is disposed in the wall such that as the bioabsorbable member extends through the access port, the external portion is disposed on a exterior side of the wall and the interior portion is disposed on an interior side of the wall.
 26. A method of sealing a puncture site in a wall of a blood vessel comprising: providing an elongated element having an outer wall and defining a lumen therein, the outer wall of the elongated element having a hole therein providing access to the lumen; releasably attaching a bioabsorbable member to the elongated element by inserting the bioabsorbable member into the hole in the wall of the elongated element such that a first portion of the bioabsorbable member is within the lumen of the elongated element and a second portion of the bioabsorbable member is outside of the lumen; placing the elongated element and attached bioabsorbable member into the anatomy of a patient; advancing the elongated element in the anatomy, wherein the advancement causes the first portion of the bioabsorbable member to evacuate the lumen of the elongated element.
 27. The method of claim 26, wherein the second portion of the bioabsorbable member includes a cuff portion, and the cuff is positioned on the elongated element such that the step of placing the elongated element into the anatomy causes the cuff to abut the anatomy and the abutment of the cuff to anatomy prevents the cuff from advancing during the advancing step and causes the first portion of the bioabsorbable member to evacuate the lumen as the elongated element is advanced.
 28. The method of claim 26, further including the step of retracting a tether coupled to the bioabsorbable member to cause the first portion of the bioabsorbable member to abut the puncture site.
 29. The method of claim 26, wherein the placing step puts the entire bioabsorbable member within the anatomy.
 30. The method of claim 26, wherein the placing step places the hole in the wall of the elongated element within the puncture site.
 31. A device for sealing a puncture site comprising: an elongated element having a length adapted to be inserted into the puncture site and having a lumen therein, the elongated element further including a distal end access port, a proximal end access port, and a side access port, each of the access ports providing access to the lumen, and a bioabsorbable member including: an external portion disposed on the exterior of the elongated element, a portion extending through the side access port of the elongated element, and an internal portion disposed within the lumen, the bioabsorbable member being releasably fixed to the elongated element.
 32. The device of claim 31, wherein the bioabsorbable member is pre-loaded onto the elongated element prior to use.
 33. The device of claim 31, wherein the bioabsorbable member is a sheet of bioabsorbable material.
 34. The device of claim 31, wherein the external portion of the bioabsorbable member forms a cuff having a lumen that receives the elongated element therein.
 35. The device of claim 31, wherein the external portion, the portion extending through the side access port and the internal portion are of made of a substantially homogenous and continuous material.
 36. The device of claim 31, further including a removable tether, wherein removing the tether permits the bioabsorbable member to move relative to the elongated element.
 37. The device of claim 31, further including a tether that is woven into the bioabsorbable member prior to use. 